AMPOWER: PHASE 3 STUDY DESIGN1
- Single-arm, open-label trial
- 112 sites
- 1384 women aged 18 to 35
- Primary endpoint: 7-cycle cumulative pregnancy rate as calculated by the Kaplan-Meier method
KEY INCLUSION CRITERIA1,a
- Healthy and sexually active, within the age range of 18 to 35 years old, at risk of pregnancy and desiring contraception
- Had a normal, cyclic menses with a usual length of 21 to 35 days over the last 2 cycles or at least 2 consecutive spontaneous menses (21-35 days in length) since delivery, abortion, or after discontinuing hormonal contraception or hormonal therapy
- At low risk for both human immunodeficiency virus (HIV) and sexually transmitted infectionsb
- At the time of enrollment, had a single male sex partner for ≥3 months
- Was willing to engage in at least 3 acts of heterosexual vaginal intercourse per cycle
- Was willing to use the study drug as the only method of contraception over the course of the studyc
- Willing to report all information in a daily eDiary
aThis is not an exhaustive list of inclusion criteria.
bIn the opinion of the investigator, based on review of high-risk behaviors and exposures according to the Centers for Disease Control and Prevention (CDC) STI Guideline.
cWith the exception of emergency contraception in the event a subject engaged in vaginal intercourse but believed that the study drug was not used properly or she was at risk for pregnancy for any other reason.